Manufacturer's Devices - Gynesonics Inc.

Address:




600 Chesapeake Drive



Reedwood City

CA 94063

United States


Authorised Representative/ UK Responsible Person
Name: Obelis UK Ltd
Address:

Sandford Gate East Point Business Park



Oxford

OX4 6LB

England United Kingdom




Code/Term Type
Ultrasound-guided intrauterine radio-frequency ablation systemUltrasound-guided intrauterine radio-frequency ablation systemClass IIb
Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrodeUltrasound-guided intrauterine radio-frequency ablation system handpiece/electrodeClass IIb
Electrosurgical return electrode single-useElectrosurgical return electrode single-useClass IIa
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Sterilization packaging single-useSterilization packaging single-useClass I
Specimen container mailer non-insulatedSpecimen container mailer non-insulatedClass I
Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer reusableUltrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer reusableClass IIa
Non-submersible device disinfection chamberNon-submersible device disinfection chamberClass I
Invasive medical device leak tester mechanicalInvasive medical device leak tester mechanicalClass I
Invasive medical device leak tester mechanicalInvasive medical device leak tester mechanical
Ultrasound-guided intrauterine radio-frequency ablation system handpiece/electrodeUltrasound-guided intrauterine radio-frequency ablation system handpiece/electrodeClass IIb
Ultrasound-guided intrauterine radio-frequency ablation systemUltrasound-guided intrauterine radio-frequency ablation systemClass IIb
Electrosurgical return electrode single-useElectrosurgical return electrode single-useClass IIb
Ultrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer single-useUltrasound-guided intrauterine radio-frequency ablation system intrauterine ultrasound transducer single-useClass IIa
Electrical-only medical device connection cable reusableElectrical-only medical device connection cable reusableClass I
Specimen container mailer non-insulatedSpecimen container mailer non-insulatedClass I
Sterilization packaging single-useSterilization packaging single-useClass I